68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer
Early Detection, Accurate Staging, and Biologic Characterization of HCC With Hybrid 68Ga-PSMA-Dual -Contrast PET/MRI and PET/CT Using Cyclotron-Produced 68Ga
3 other identifiers
interventional
52
1 country
1
Brief Summary
This phase II trial studies how well 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer. 68Gallium-PSMA is a radioactive tracer designed to circulate through the body and attach itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. Magnetic resonance imaging (MRI) is a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues, and structures within the body. Positron emission tomography (PET) is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (tracer) to show this activity. Computed tomography (CT) scan uses X-rays to create images of the bones and internal organs within your body. Combining a PET scan with an MRI or CT scan may help make the images easier to interpret. This trial may help determine if 68Ga- PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hepatocellular-carcinoma
Started Feb 2021
Typical duration for phase_2 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedStudy Start
First participant enrolled
February 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2025
CompletedOctober 31, 2025
October 1, 2025
4.3 years
February 11, 2021
October 9, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Diagnostic performance of 68Ga-PSMA-dual contrast
Using surgical histopathology of resected or biopsied lesions and routine imaging surveillance (for lesions that cannot be resected or biopsied) as the gold standard, we will estimate the diagnostic performance (lesion-level sensitivity, specificity measures, and corresponding 95% confidence intervals) of PET/MRI for hepatic lesions and extra-hepatic metastases, and compare it with standard-of-care (SOC) imaging (MRI and CT) to identify the incremental benefit of PET/MRI.
Up to 6 weeks
Correlate biomarkers derived from PET/MRI with PSMA immuno-histochemical (IHC) grading
PSMA stained sections will be evaluated by light microscopy for PSMA localization and the entire section reviewed to determine percentage area of PSMA immunostaining as follows: 0 = no staining, 1 = \< 5% staining, 2= 5 to 30% staining, 3 = 31 to 60% staining, and 4 = 61-100% staining. Grades 0-2 will be grouped as 'low PSMA expression' and grades 3 and 4 will be grouped as 'high PSMA expression'
Up to 6 weeks
Correlate biomarkers derived from PET/MRI with PSMA immuno-histochemical (IHC) grading
Intensity of PSMA uptake in hepatic lesions on PET will be graded as follows: grade 1: uptake \< normal liver; grade 2: uptake = normal liver; grade 3: uptake \> normal liver; grade 4: uptake \> spleen or kidneys. For correlation with PSMA IHC scoring, grades 1 and 2 on PET/MRI will be grouped as 'low PSMA expression'. Conversely, grades 3 and 4 will be grouped as 'high PSMA expression'.
Up to 6 weeks
Study Arms (1)
Diagnostic (68Ga-PSMA PET/MRI or PET/CT)
EXPERIMENTALPatients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
Interventions
Undergo PET/CT
Given IV
Undergo PET/MRI
PET/MRI or PET/CT
Eligibility Criteria
You may qualify if:
- Patients with either an imaging diagnosis of Hepatocellular carcinoma (HCC) by Computed Tomography (CT) or Magnetic Resonance Imaging MRI (Liver Imaging Reporting and Data System \[LI-RADS\] 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
- Subjects who may undergo hepatic surgical resection, liver transplant, or hepatic locoregional therapy (LRT) (e.g., ablation, embolization, etc.)
- No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm). Patients that have been previously treated with HCC, but have new or reoccurring untreated lesions, are included in the study.
- Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent.
You may not qualify if:
- Patients requiring emergent surgery for a ruptured/bleeding HCC
- Bilirubin \> 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent (relevant to positron emission tomography \[PET\]/MRI)
- Patients with glomerular filtration rate (GFR) \< 30 ml/min/1.73m\^2, on dialysis, or with acute kidney injury
- Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan
- Patients with higher than the weight/size limitations of PET/MRI or PET/CT scanner
- Subjects with history of allergic response to Eovist or Gadavist
- Subjects with known history of claustrophobia
- Subjects with GFR \< 30 ml/min/1.73m\^2, on dialysis, or with acute kidney injury
- Subjects with a history of severe hypersensitivity to Eovist or Gadavist
- Patients with contraindication to MRI (relevant to PET/MRI):
- Patients who have a heart pacemaker
- Patients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain
- Patients who have implanted devices with magnets
- Patients who have other implanted electronic devices
- Patients who have deep brain stimulator
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- United States Department of Defensecollaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ajit H. Goenka, M.D.
Mayo Clinic in Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2021
First Posted
February 21, 2021
Study Start
February 24, 2021
Primary Completion
June 26, 2025
Study Completion
June 26, 2025
Last Updated
October 31, 2025
Record last verified: 2025-10